Methods and systems for controlled deployment of needles in tissue

ABSTRACT

Needles are deployed in tissue under direct ultrasonic or other imaging. To aid in deploying the needle, a visual needle guide is projected on to the image prior to needle deployment. Once the needle guide is properly aligned, the needle can be deployed. After needle deployment, a safety boundary and treatment region are projected on to the screen. After confirming that the safety boundary and treatment regions are sufficient, the patient can be treated using the needle.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.15/595,659, filed May 15, 2017; which is a continuation of U.S. patentapplication Ser. No. 13/589,975, filed Aug. 20, 2012; which is acontinuation of U.S. patent application Ser. No. 13/307,304, filed Nov.30, 2011, now U.S. Pat. No. 8,262,577; which is a continuation of U.S.patent application Ser. No. 12/245,567, filed on Oct. 3, 2008, now U.S.Pat. No. 8,088,072; which claims the benefit of Provisional ApplicationNo. 60/979,613, filed Oct. 12, 2007; the full disclosures of which areincorporated herein by reference.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The present invention relates generally to medical methods andapparatus. More particularly, the present invention relates to methodsand systems for controlling the deployment of needles using visualfeedback from an ultrasonic or other image.

Current medical treatments of organs and tissues within a patient's bodyoften use a needle or other elongate body for delivery of energy,therapeutic agents or the like. Optionally the methods use ultrasoundimaging to observe and identify a treatment target and the position ofthe needle relative to the treatment target.

Of particular interest to the present invention, a treatment for uterinefibroids has recently been proposed which relies on the transvaginalpositioning of a treatment device in the patient's uterus. Aradiofrequency or other energy or therapeutic delivery needle isdeployed from the device into the fibroid, and energy and/or therapeuticsubstances are delivered in order to ablate or treat the fibroid. Tofacilitate locating the fibroids and positioning the needles within thefibroids, the device includes an on-board ultrasonic imaging array witha field of view in a generally lateral direction from an axial shaft. Acurved needle is advanced from the shaft and into the field of view sothat the needle can be visualized and directed into the tissue and thetargeted fibroid. The geometry of the needle deployment is advantageoussince it permits the location and treatment of fibroids which arelaterally adjacent to the shaft.

While effective and very beneficial for patients, such needle ablationand treatment protocols face several challenges. First, initialdeployment of the needle can be difficult, particularly for physicianswho have less experience. While the physician can view the tissue andtarget anatomy in real time on an imaging screen, it can be difficult toprecisely predict the path the needle will take and assess its finaltreatment position. While the needle can certainly be partially or fullyretracted and redeployed, it would be advantageous to minimize thenumber of deployments required before treatment is effected.

A second challenge comes after the needle has been deployed. While theposition of the needle can be observed on the ultrasonic or other visualimage, the treatment volume resulting from energy or other therapeuticdelivery can be difficult to predict. As with initial positioning,experience will help but the need to exercise judgment and conjecture isbest reduced.

A third challenge is in assuring that nearby sensitive tissuestructures, such as the serosa surrounding the myometrium, are notunintentionally damaged. As with judging the treatment volume,predicting the safety margin of the treatment can be difficult.

For these reasons, it would be desirable to provide improved systems andmethods for the deployment of energy delivery and other needles withinultrasonic or other imaging fields of view in energy delivery or othertherapeutic protocols. It would be particularly useful to provide thetreating physician with information which would assist in initialdeployment of a needle in order to improve the likelihood that theneedle will be properly positioned relative to a targeted anatomy to betreated. It would also be desirable, once the needle has been deployed,to provide feedback to the physician to assist in accurately predictinga treatment volume. Such information should allow the physician, ifnecessary, to reposition the needle in order to increase the likelihoodof fully treating the anatomy. Furthermore, it would be desirable toprovide feedback to the physician allowing the physician to assess asafety margin so that sensitive tissue structures are not damaged. Allsuch feedback other information are preferably provided visually on theultrasonic or other imaging screen so that the needle position can bequickly predicted, assessed, and treatment initiated. At least some ofthese objectives will be met by the inventions described hereinafter.

2. Description of the Background Art

U.S. Patent Publication No. 2006/0189972, published on Aug. 24, 2006 andcommonly assigned with the present application, describes probes usefulfor both imaging and treating uterine fibroids, which probes could beused in the systems and methods of the present application. Othercommonly assigned applications describing probes useful for treatinguterine fibroids in the systems and methods of the present inventioninclude application Ser. No. 11/409,496, filed on Apr. 20, 2006; Ser.No. 11/564,164, filed on Nov. 20, 2006; Ser. No. 11/620,594, filed onJan. 5, 2007; and copending provisional application No. 60/938,140,filed on May 15, 2007, the full disclosures of which are incorporatedherein by reference. Other related, commonly assigned applications areSer. No. 11/620,569, filed Jan. 5, 2007; and Ser. No. 11/775,452, filedon Jul. 10, 2007. The full disclosures of each of these commonly owned,pending applications are incorporated herein by reference.

BRIEF SUMMARY OF THE INVENTION

The present invention provides both methods and systems for deployingone or more needles in tissue. The needles are usually intended todeliver a therapy to the tissue, most typically being adapted to deliverradiofrequency, plasma, heat, or other energy to ablate or otherwisemodify the tissue or a targeted anatomy within the tissue. In otherembodiments of the present invention, however, particularly thoserelating to initial needle deployment, the needles could also beintended for biopsy or have other diagnostic purposes.

One or more needles are deployed in tissue where the tissue is beingimaged so that at least a portion of the needle (once deployed) and atleast one anatomical feature within the tissue will be visible,preferably on a display screen in real time before, after, and/or duringneedle deployment. In a first specific aspect of the present invention,the image is overlaid with projected needle treatment information. By“projected,” it is meant that the needle treatment information ispredicted or calculated based on known or determined system information.For example, the shape of the needle and mechanics of the needledeployment system may be used to predict the path that the needle maytake into tissue, as described in greater detail below. The treatmentvolume and safety boundaries or margins may be calculated or predictedbased on the energy delivery characteristics of the system together withthe anticipated tissue characteristics. The information overlaid on theimage will allow a user, typically a treating physician, to evaluate thepredicted and/or actual needle positions relative to both treatmentefficacy and safety.

In the exemplary embodiments, at least one needle will be deployed froma probe where the probe may be introduced to the uterus or other bodycavity or lumen. Exemplary anatomical features that may be imaged andsubsequently treated or biopsied include fibroids, tumors, encapsulatedtissue masses, pseudoencapsulated tissue masses, and the like. Ofparticular interest to the present invention, the probe may bepositioned in the uterus and the needle deployed to a location proximateor into a fibroid located in the myometrium surrounding the uterus. Insuch cases, it will usually be desirable to also image the serosa whichsurrounds the myometrium and/or other sensitive anatomical features thatcould be damaged by the energy-mediated or other therapeutic treatment.

Thus, in a first specific aspect of the present invention, the projectedneedle information will include at least a projected safety boundarywhich provides a visual image of the treatment volume that can beprovided through the needle. In such cases, evaluating can compriseconfirming that the serosa or other sensitive tissue or anatomicalstructure is outside of the projected safety boundary (where tissuewithin the projected safety boundary is at risk of tissue damage). Theprojected safety boundary will usually provide a minimum distancebetween the needle and the serosa or other sensitive anatomical featurewhich is at least 0.5 cm, often being at least 0.7 cm, and preferablybeing at least 1 cm.

In a second specific aspect of the present invention, the projectedneedle treatment information will comprise a projected needle deploymentpath. The projected needle deployment path will typically find use priorto needle deployment where the treating physician can manipulate theprobe which carries the needle so that the projected needle treatmentpath visible on the display screen is aligned so that the needle willenter or at least be reasonably close to the targeted anatomy to betreated. The projected needle treatment information will be based on theknown mechanical characteristics of the needle and may vary fordifferent needles. In some instances, it will be desirable to actuallytest individual needles which are being used so that their individualcharacteristics are known, but this will usually not be necessary. Itwill be appreciated that the actual needle entry path, while predictablewithin certain tolerances, may differ from the projected path due todifferences in the tissue characteristics, small differences in thedeployment mechanisms, differences in the needle characteristics, orother reasons. In such instances, the methods and systems of the presentinvention will allow for inputting the actual treatment position so thatthe safety and treatment boundaries can be predicted based on the actualneedle position, not the predicted needle position. For example, thephysician may locate a known point or artifact on the needle whichappears in the visual image. By then “clicking on” that point orotherwise feeding that positional information back into the imaging andcontrol system, the system can recalculate the actual needle positionand, based on the actual position, calculate the safety and treatmentboundaries.

In a third specific aspect of the present invention, the projectedneedle treatment information comprises a projected therapy region. Theprojected therapy region will be a boundary or volume which is shown onthe visual display to allow the treating physician to assess whether thetarget region to be treated will likely be effectively treated based onthe needle position. As just discussed, usually the projected needletreatment information is preferably based on the actual needle positionbut could also be based on the projected needle position. Thus, it maybe possible for the treating physician to rely on a projected therapyregion (as well as a projected safety boundary) while the projectedneedle position is being manipulated relative to the targeted anatomy tobe treated. After actual deployment, the system can recalculate both theprojected therapy region and the projected safety boundary to allow thetreating physician to confirm both that the treatment will likely beeffective and that the serosa and/or other sensitive tissue structureswill not be damaged.

In a further specific aspect of the present invention, the treatmentsystem will provide for an interlock or enablement step before treatmentcan be delivered to the tissue. For example, the system may require thetreating physician to acknowledge that either or both of the safetyboundary and treatment volumes have been observed and evaluated todetermine that the treatment will be safe and/or effective. Without suchacknowledgement, the system could preclude energy delivery until suchtime as the treating physician acknowledges evaluation of the safetyand/or effectiveness. In other instances, the system could be modifiedto assess the projected boundaries relative to the targeted treatmentanatomies and the sensitive tissue anatomy, although such fullyautomated systems are not presently preferred.

The methods of the present invention will preferably employ the uterinefibroid treatment probes, such as those described in the commonly owned,copending applications incorporated herein by reference above. Thesetreatment probes comprise a shaft having both an imaging transducer anda deployable needle near the distal end. The needle is configured sothat it may be selectively advanced in a generally lateral directionwithin the field of image of the transducer, typically an ultrasonicimaging array. After the needle has been advanced into the tissue, andthe safety and effectiveness of the needle position have been confirmed,therapy may be administered through the needle, such as radiofrequencytissue treatment or other energy or non-energy mediated treatments.Exemplary energy treatment modalities include radiofrequency, microwave,high intensity focused ultrasound (HIFU), liquid infusion, plasmainfusion, vapor, cryotherapy, and the like.

In another embodiment of the present invention, a needle is deployed intissue by first positioning a probe having a deployable needle proximatea surface of the tissue. An image of the tissue is provided in realtime, and a projected needle path is overlaid on the image. Prior toactually deploying the needle, the probe is repositioned to align theprojected needle path on the real time image with anatomical feature.After the probe has been repositioned to optimize the position of theprojected needle path within the anatomical feature, the needle may bedeployed from the probe. After the needle has been actually deployed,the actual needle position may be fed back into the imaging system bymarking a location on an image of the needle. Based on the actual needleposition provided by the marked location, the projected safety boundarymay be calculated by the system and overlaid on the image. Based on theprojected safety boundary, the physician may visually confirm thatsensitive anatomic structures are safe. Usually, the tissue image willalso be overlaid with a projected treatment boundary based on the markedlocation. The physician may then also visually confirm that at least aportion of the anatomical feature to be treated is within the projectedtreatment boundary. The system may also be programmed so that thetreatment device will be enabled only if the sensitive anatomicstructures are outside of the safety boundary, typically by requiringthe treating physician to acknowledge that the anatomical structures aresafe.

Systems for deploying needles in tissue in accordance with theprinciples of the present invention comprise a probe and a systemcontroller. The probe includes one or more deployable needles and animaging transducer, where the needle(s) is (are) configured to beadvanced into an image field produced by the imaging transducer. Thesystem controller includes a screen for displaying the image produced bythe transducer, where the system controller provides for an overlay onthe screen with projected needle treatment information. The projectedneedle treatment information may comprise a projected needle path, wherethe physician can manipulate the probe to align the projected needlepath with a target anatomy in the image field visible on the screen. Theneedle information may further comprise a projected treatment boundaryand/or projected safety boundary. In such instances, the system mayrequire the physician to confirm that the projected or actual needleposition is safe and/or effective prior to enabling a therapy. Usually,the system will be able to update the projected needle information basedon the actual needle position. In exemplary systems, the systemcontroller further includes a generator for producing a therapy to bedelivered through the needle, such as a radiofrequency, microwave, highintensity focused ultrasound (HIFU), vapor, liquid infusion, andcryotherapy. Systems may employ needle arrays comprising multipleneedles.

Methods for treating fibroids and other anatomical features furthercomprise deploying at least one needle in the uterus proximate, usuallywithin, the anatomical feature. The methods may deploy multiple needlesin needle arrays. Radiofrequency energy is delivered into the featurethrough an exposed portion or portions of the needle, where no exposedneedle portion is closer than 0.5 cm to the serosa, usually being nocloser than 0.7 cm, and preferably being no closer than 1 cm. suchmethods can achieve effecting treatment of many or most fibroids orother features without damaging the serosa.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of the system comprising a systemcontroller and a needle treatment probe constructed in accordance withthe principles of the present invention.

FIGS. 2 through 4 illustrate an exemplary needle treatment probe whichmay be used in the methods and systems of the present invention for thetreatment of uterine fibroids.

FIG. 5 is a flowchart illustrating an exemplary treatment protocol inaccordance with the principles of the present invention.

FIGS. 6A and 6B illustrate use of the needle treatment probe of FIGS. 2through 4 in the treatment of a uterine fibroid in accordance with theprinciples of the present invention.

FIG. 7 illustrates exemplary dimensions for a treatment region and asafety boundary for the needle deployment probe of FIGS. 2 through 4.

FIGS. 8A through 8G illustrate exemplary images which might be viewed bya treating physician when deploying the needle deployment probe of FIGS.2 through 4 in treating a uterine fibroid generally as shown in FIGS. 6Aand 6B.

DETAILED DESCRIPTION OF THE INVENTION

As illustrated in FIG. 1, a system 10 constructed in accordance with theprinciples of the present invention includes both a system controller 12and treatment probe 14. The system controller 12 will include aprocessing and power unit 16 and a display screen 18. The controller 12will further include means for the treating physician to inputinformation, such as a keyboard, touch screen, control panel, or thelike. The processing and power unit 16 will usually include aradiofrequency, microwave, vapor, treatment plasma, or other circuitryor mechanisms for delivering the treatment energy or other treatmentagents to the treatment probe 14. Conveniently, the system controller 12could comprise a conventional desktop or laptop computer to provide boththe screen and logic and be connected to a separate radiofrequency,microwave, HIFU, liquid infusion, plasma infusion, vapor, cryotherapy orother source to provide the desired treatment.

The treatment probe 14 typically includes a shaft 20 having a handle 22at its proximal end. A needle 24 and imaging array 26 are provided atthe distal end of the shaft 20, as described in more detail withreference to FIGS. 2 through 4. The treatment probe 14 shown in FIGS. 2through 4 is described in more detail in copending provisionalapplication No. 60/938,140, filed on May 15, 2007, the full disclosureof which has previously been incorporated herein by reference.

The probe 14 generally includes a rigid or other delivery shaft 20, anultrasound imaging transducer 26, and an echogenic curved needle 24 withan artifact/feature 100 at a distal end 51 (FIG. 3) thereof. As shown,the artifact is a corner cut type retroreflector. The handle 22 isattached to a proximal end 21 of the shaft 20. A distal end 23 of theshaft 20 has a bent or deflectable distal tip, as best seen in FIG. 4.The ultrasound imaging transducer 26 comprises a linear ultrasound arraydisposed in a flat viewing window 36 (FIG. 3) which images in a field ofview 46 (FIG. 4). Although only a single straight needle 24 isillustrated, the probe may carry multiple needles in arrays and/or theneedles may be straight or have any other configuration.

The needle 24 is a solid tip electrically conductive needle intended forradiofrequency tissue ablation. As discussed elsewhere, it could also beintended for delivery of other forms of energy or be a hollow coreneedle intended for substance delivery or injection. The exemplaryneedle 24 generally comprises a two-piece construction including anelongate hollow body 48 (as best seen in FIG. 3) and a solid distal tip50 at a distal end thereof. The distal tip 50 may be laser welded to thehollow tubular body 48. The solid tip 50 may also be attached viaalternative means, for example adhesives or mechanical features or fits.The hollow tube 48 will generally have a length in a range from about 20cm to about 45 cm. In some embodiments, the hollow tube will have anoval cross section having a thickness generally in a range from about0.5 mm to about 2 mm and a wideness generally in a range from about 1 mmto about 3 mm. This flattened oval cross sectional shape, when present,is intended to inhibit lateral deflection during deployment orpenetration of the needle 24. FIG. 3 also illustrates a representativelaser cut hole 60 within the distal end of the tubular body 48 for theinfusion of agents (e.g., electrolytes, drugs, etc.) so as to enhancethe therapeutic effect of the needle 14 prior to or during ablationtreatment. The infusion hole 60 may be aligned on one side of thetubular body 48 and generally has length in a range from about 0.5 mm toabout 2 mm and a width in a range from about 0.5 mm to about 2 mm. Itshould be noted that hole 60 may comprise one or a plurality of holes,and each may be used for a different purpose.

The handle 24 further includes a longitudinally movable slider 72 forenabling the advancement and retraction of the needle 14 to and fromwithin a needle guide 44. The ultrasound imaging transducer 26 mayoptionally be present on an imaging insert replaceably disposed withinthe axial passage of the shaft 20. A sealing element 30 may be providedbetween the ultrasound imaging transducer 26 and the shaft handle 24 toensure sufficient sealing around the insert at a proximal end. It willbe appreciated that the above depictions are for illustrative purposesonly and do not necessarily reflect the actual shape, size, ordimensions of the system 10. Furthermore, the ultrasound array may beparallel to an axis of the shaft 20 or may be slightly inclined asillustrated in FIG. 4. This applies to all depictions hereinafter. Thearray is typically a linear array with from 16 to 128 elements, usuallyhaving 64 elements. The length (azimuth) of array 12 usually ranges fromabout 5 mm to about 20 mm, normally being about 14 mm. The array mayhave a depth (elevation) ranging from about 1 mm to about 8 mm, normallybeing about 2 mm. In an embodiment, the ultrasound array transmitsultrasound waves at a center frequency ranging from about 2 MHz to about15 MHz, typically from about 5 MHz to about 12 MHz, normally about 6.5MHz.

Referring now to FIG. 5, an exemplary protocol for performing the needlepositioning methods of the present invention for treating uterinefibroids will be described. After the probe 14 is positioned in theuterus, the treating physician scans the myometrium M in order to locatefibroids F, as shown in FIG. 6A. Shaft 20 is manipulated so that thefield of view 46 of the transducer array 26 provides a visual image,such as that shown in FIG. 8A, on the screen 18 of the system 12. Once afibroid F is located, the physician can scan the image for otheranatomical features such as the treatment-sensitive serosa S, as alsoshown in FIG. 8A. It should be appreciated that the image being producedis “real time,” and that the image will change as the physician movesthe shaft 20 within the uterus U so that the field of view 46 scans overdifferent portions of the myometrium.

The next step in the protocol of FIG. 5 relies on aligning a needleguide overlay with the fibroid. The needle guide may be a simple pair ofparallel lines 70, as shown in FIG. 8B. The parallel lines 70 willtypically represent the limits of the most likely lateral needleadvancement path. Thus, by aligning the lines 70 generally across thetarget fibroid F, as shown in FIG. 8C, the likelihood that the needlewill be directed into the middle of the fibroid is increased.

The treating physician continues to visually assess the position of theneedle guidelines 70 relative to the fibroid F until they are acceptablyaligned, as shown in FIG. 8C. The physician then advances the actualneedle into the tissue as shown in FIG. 6B, where the image of theactual needle is shown in FIG. 8D. After the image of the actualposition of the needle appears, the physician marks a preselectedposition on the needle, either by moving a curser on the image andclicking, touching the screen, or the like. Such “marking” of the actualposition allows the system to calculate or recalculate a projectedsafety boundary and a projected therapy region. For example, the systemmay be marked near the tip of the needle, as shown at location 80 onFIG. 8E.

Referring now to FIG. 7, an exemplary safety boundary 90 and treatmentregion 92 for a single needle fibroid ablation system will be described.A treatment needle 24 has an uninsulated treatment portion 96 having alength 1 in the range from 1 cm to 3 cm, typically being 2 cm. Thesafety boundary will be an oval line which is generally a distance sfrom the exposed exterior of the treating electrode portion 96. Thedistance s is usually in the range from 1 cm to 3 cm, typically beingabout 1.5 cm. A distance t between the exposed needle portion 96 and thetreatment region boundary 92 will typically be about half that of thesafety distance s, typically being in the range from 0.5 cm to 1.5 cm,usually being about 0.75 cm. Generally, the distance tt from the distaltip of the needle 24 and the safety boundary and the treatment regionperimeter will be somewhat less because of the reduced energy density atthe tip. Thus, the distance tt between the tip and the treatment regionperimeter may be from 0.1 cm to 0.5 cm, usually being about 0.25 cmwhile the distance is between the tip and the safety boundary will be inthe range from 0.5 cm to 1.5 cm, typically being about 1 cm.

Based on these desired clearance distances, the system projectstreatment and safety overlays on the actual image of the needle 24, asshown in FIG. 8F. The physician can then visually assess whethersensitive tissue structures, such as the serosa S remain outside of theprojected safety boundary 90. As shown in FIG. 8F, the serosa S isinside of the safety boundary 90, so it will be necessary to repositionor redeploy the needle 24 to move the serosa S beyond the safetyboundary. It is noted that the position of the treatment perimeter 92about the fibroid F is probably sufficient for treatment, but the needleneeds to be deployed based on safety concerns.

Once the needle has been repositioned or redeployed so that thetreatment region 92 sufficiently covers the fibroid F while the safetyboundary does not encroach upon the serosa S as shown in FIG. 8G, thephysician will enable the system for treatment. Usually, the system willrequire the physician to acknowledge that the needle has been properlypositioned before allowing the system to power the needle. Once that isdone, the physician can initiate treatment, as described generally inthe prior applications which have been incorporated herein by reference.

While the above is a complete description of the preferred embodimentsof the invention, various alternatives, modifications, and equivalentsmay be used. Therefore, the above description should not be taken aslimiting the scope of the invention which is defined by the appendedclaims.

What is claimed is:
 1. A system for treating uterine anatomy, the systemcomprising: an ultrasound imaging device configured to produce areal-time image of the uterine anatomy including a uterine fibroid to betreated; a radiofrequency ablation device comprising a needle arraycomprising multiple needles, wherein the needle array is deployable intothe uterine fibroid; and a system controller comprising: a screen fordisplaying the real-time image of the uterine anatomy produced by theultrasound imaging device; a radiofrequency generator; and a processingunit programmed to: overlay a projected treatment boundary or projectedtreatment volume based on a position of the needle array onto thereal-time ultrasound image of the uterine anatomy; recalculate theprojected treatment boundary or projected treatment volume based on anactual position of the needle array deployed into the uterine fibroid;and deliver radiofrequency energy from the radiofrequency generatorthrough the needle array after recalculating the projected treatmentboundary or projected treatment volume and with at least a portion ofthe uterine fibroid positioned within the recalculated projectedtreatment boundary or projected treatment volume on the real-timeultrasound image.
 2. The system of claim 1, wherein the processing unitis programmed to overlay the projected treatment boundary or projectedtreatment volume based on a position of the needle array onto thereal-time ultrasound image of the uterine anatomy prior to deploying theneedle array into the uterine fibroid.
 3. The system of claim 1, whereinthe processing unit is programmed to overlay onto the real-timeultrasound image a projected needle path of the radiofrequency ablationdevice as the radiofrequency ablation device is being manipulatedrelative to the uterine fibroid to be treated.
 4. The system of claim 1,wherein the processing unit is programmed to prevent the delivering ofradiofrequency energy until confirmation indicative of treatment beingsafe or effective.
 5. A system for treating uterine anatomy, the systemcomprising: an ultrasound imaging device configured to produce areal-time image of the uterine anatomy including an anatomical featureto be treated; a tissue treatment device comprising one or more needles;and a system controller comprising: a screen for displaying thereal-time image of the uterine anatomy produced by the ultrasoundimaging device; and a processing unit programmed to: overlay onto thereal-time ultrasound image of the uterine anatomy projected needletreatment information of the tissue treatment device when the tissuetreatment device is positioned proximate to the uterine anatomy, whereinthe projected needle treatment information is predicted based on adeployed position of the one or more needles, and wherein the projectedneedle treatment information includes a projected treatment boundarysurrounding a portion of the one or more needles when in a deployedposition; align the projected needle treatment information on thereal-time ultrasound image with the anatomical feature to be treatedsuch that at least a portion of the anatomical feature to be treated iswithin the projected treatment boundary; recalculate the projectedtreatment boundary based on an actual position of the one or moreneedles deployed into the anatomical feature to be treated; and deliverenergy through the one or more needles to treat the anatomical featureafter aligning the projected needle treatment information on thereal-time ultrasound image and with the one or more needles deployedinto the anatomical feature to be treated and after recalculating theprojected treatment boundary.
 6. The system of claim 5, wherein theprocessing unit is programmed to overlay the projected treatmentboundary onto the real-time ultrasound image after the one or moreneedles of the tissue treatment device are deployed into the anatomicalfeature.
 7. The system of claim 5, wherein the processing unit isprogrammed to overlay the projected treatment boundary onto thereal-time ultrasound image before the one or more needles of the tissuetreatment device are deployed into the anatomical feature to be treated.8. The system of claim 5, wherein the anatomical feature to be treatedcomprises a uterine fibroid.
 9. The system of claim 5, wherein theprocessing unit is programmed to overlay onto the real-time ultrasoundimage a projected needle deployment path.
 10. The system of claim 5,wherein the processing unit is programmed to overlay onto the real-timeultrasound image a safety boundary based on the deployed position of theone or more needles of the tissue treatment device.
 11. A system fortreating uterine anatomy, the system comprising: an ultrasound imagingdevice configured to produce a real-time image of the uterine anatomyincluding an anatomical feature to be treated; a tissue treatment devicecomprising one or more needles; and a system controller comprising: ascreen for displaying the real-time image of the uterine anatomyproduced by the ultrasound imaging device; and a processing unitprogrammed to: overlay onto the real-time ultrasound image a projectedneedle path of the tissue treatment device when positioned proximate tothe uterine anatomy; overlay onto the real-time ultrasound image aprojected treatment boundary or projected treatment volume based on adeployed position of the one or more needles of the tissue treatmentdevice, wherein at least a portion of the anatomical feature to betreated is within the projected treatment boundary or projectedtreatment volume; recalculate the projected treatment boundary orprojected treatment volume based on an actual position of the one ormore needles deployed into the anatomical feature to be treated; anddeliver energy through the one or more needles to treat the anatomicalfeature after the projected treatment boundary or projected treatmentvolume is overlaid onto the real-time ultrasound image and with the oneor more needles deployed into the anatomical feature to be treated andafter the projected treatment boundary or projected treatment volume isrecalculated.
 12. The system of claim 11, wherein the tissue treatmentdevice comprises an array of multiple needles.
 13. The system of claim11, wherein the processing unit is programmed to overlay the projectedtreatment boundary or projected treatment volume onto the real-timeultrasound image after the one or more needles are deployed into theanatomical feature to be treated.
 14. The system of claim 11, theprocessing unit is programmed to overlay the projected treatmentboundary or projected treatment volume onto the real-time ultrasoundimage before the one or more needles are deployed into the anatomicalfeature to be treated.
 15. The system of claim 11, wherein theprocessing unit is programmed to overlay the projected needle path andthe projected treatment boundary or projected treatment volumesimultaneously onto the real-time ultrasound image.
 16. The system ofclaim 15, wherein the processing unit is programmed to overlay theprojected treatment boundary or projected treatment volume onto thereal-time ultrasound image while the projected needle path is beingmanipulated relative to the anatomical feature to be treated.
 17. Thesystem of claim 11, wherein the projected treatment boundary orprojected treatment volume surrounds a portion of the one or moreneedles when in the deployed position.
 18. The system of claim 17,wherein the projected treatment boundary or projected treatment volumehas an oval shape.
 19. The system of claim 11, wherein the processingunit is programmed to overlay the projected needle path and theprojected treatment boundary or projected treatment volume onto an imageof the one or more needles of the tissue treatment device.
 20. Thesystem of claim 11, wherein the anatomical feature to be treatedcomprises a uterine fibroid.
 21. The system of claim 11, wherein theprocessing unit is programmed to overlay onto the real-time ultrasoundimage a safety boundary based on the deployed position of the one ormore needles of the tissue treatment device.